Cleared Traditional

Madison Total Knee System

K192084 · Implanet, S.A. · Orthopedic

Oct 2019

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K192084 is an FDA 510(k) clearance for the Madison Total Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Implanet, S.A. (Martillac, FR). The FDA issued a Cleared decision on October 22, 2019, 81 days after receiving the submission on August 2, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K192084 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2019
Decision Date	October 22, 2019
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560